What you’ll do as a Risk Management Quality Engineer
As a Risk Management Engineer, you’ll be responsible for developing, implementing, and maintaining a comprehensive Risk Management System applicable to the entire product lifecycle of our Kaleido product. This includes the design, production and post-production phases. As this is a new position, we’re looking for someone who help us establish a strategic vision on risk management within ViCentra. Risk is a cross-departmental topic and as the Risk Management Quality Engineer you will be the key owner of this critical area, fostering collaboration across cross-functional teams.
Ensuring the safety and effectiveness of our products is crucial of utmost importance. Risk management plays a key role in this. Not only does it help minimise risk to patients and healthcare professionals, it also ensures that manufacturers comply with the stringent regulations required to bring medical devices to market. In this way you play a key role in ensuring and maintaining the safety and performance of our Kaleido product.
You will report to the Senior Design Assurance & NPI Manager and work together in a team with Design Quality Assurance Engineers.
Key responsibilities
• Develop and maintain a Risk Management System, ensuring compliance with international standards such as ISO 14971:2019 and regulatory requirements (EU MDR and FDA)
• Develop and coordinate creation of Risk Management Files, including Risk Management Plans, Reports, Hazard Analyse, and Traceability matrices.
• Ensure the update of Risk Management Files with production and post-production data, in close corporation with the applicable departments.
• Collaborate with R&D team to integrate risk management activities into design development and verification and validation, ensuring product reliability and safety.
• Lead risk analysis and risk control sessions, ensuring involvement from R&D and Operations team and that all product and process related risks are identified and adequately documented and mitigated.
• Ensure any design changes are assessed and updated in the Risk Management File.
• Support in internal and external audits (e.g., FDA, EU Notified Bodies), providing documentation and evidence to demonstrate compliance with ISO 14971 and related standards
About ViCentra, home of Kaleido
At ViCentra, our mission is to improve the quality of life for people with diabetes. We do this through our innovative, user-friendly solution: the Kaleido insulin pump which includes a hybrid closed loop system. Our vision is to empower people to focus on living their best lives by prioritizing simplicity, inclusivity, and personalized care in everything we do. Join us in reshaping diabetes management and making a meaningful difference in people's lives.
Who are you
This role requires a deep understanding of process and design risks, the ability to conduct robust risk assessments, and the capability to integrate risk management activities into production and manufacturing processes within the context of a Medical Devices Industry.
• You have a Bachelor's degree in Engineering or an equivalent field and at least 2-3 years of industry experience.
• You have knowledge on EU MDR, ISO 13485, ISO 14971, Design & Development. Preferred knowledge on Post Market Surveillance, Usability, Biocompatibility, or Software development.
• You can create a strategic vision for Risk Management and effectively implement it across ViCentra.
• You can drive risk management processes cross-functionally and motivate teams to take action.
• You have a continuous improvement mindset and know how to turn idea’s into results.
• You’re a critical thinker with proven problem-solving skills including root cause analysis.
Don’t meet every requirement? We value potential and encourage you to apply!
What we offer
• Meaningful work, autonomy and a salary matching your level of experience.
• 25 days of holiday per year and the opportunity to take the Dutch national holidays on any day that suits you.
• Participation in the company pension scheme.
• Subsidised gym membership, phone allowance, a tax friendly bike scheme and budget to facilitate a home office set-up.
• A diverse and inclusive work environment including a team of 45+ different nationalities.